EASY CORE BIOPSY SYSTEM

K040893 · Boston Scientific Corp · FCG · May 6, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040893
• Device Name: EASY CORE BIOPSY SYSTEM
• Applicant: Boston Scientific Corp
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: May 6, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Easy Core Biopsy System is indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs/tumors or masses for histological analysis. Soft tissue sampling includes but not limited to organs such as breast, liver, kidney and prostate. The Easy Core Biopsy System is a sterile, single-use biopsy needle.

Device Story

Easy Core Biopsy System is a sterile, single-use biopsy needle; used endoscopically or percutaneously by clinicians to retrieve soft tissue samples from organs, tumors, or masses (e.g., breast, liver, kidney, prostate) for histological analysis. Device functions as a mechanical sampling tool; no electronic or software components. Provides tissue cores for diagnostic evaluation; aids in disease diagnosis and clinical decision-making.

Clinical Evidence

Bench testing only; biocompatibility testing performed per ISO 10993.

Technological Characteristics

Sterile, single-use biopsy needle. Mechanical operation. Biocompatibility verified per ISO 10993.

Indications for Use

Indicated for endoscopic or percutaneous soft tissue biopsy (organs, tumors, masses) for histological analysis in patients requiring tissue sampling of breast, liver, kidney, or prostate.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

• ASAP Biopsy System (Stamey Sampler Spring Loaded Needle)
• ASAP 14g Biopsy System

Submission Summary (Full Text)

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MAY - 6 2004

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## Summary of Safety and Effectiveness

| General<br>Provisions | Trade Name: Easy Core™ |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: Biopsy System, Gastroenterology-urology | |
| Name of<br>Predicate<br>Devices | ASAP Biopsy System (Formally referred to as Stamey Sampler Spring<br>Loaded Needle), ASAP 14g Biopsy System. |
| Classification | Class II |
| Performance<br>Standards | Performance Standards have not been established by FDA under Section 514<br>of the Food, Drug and Cosmetic Act |
| Intended Use<br>and Device<br>Description | The Easy Core Biopsy System is indicated for use endoscopically or<br>percutaneously to retrieve tissue sampling of soft organs/tumors or masses for<br>histological analysis. Soft tissue sampling includes but not limited to organs<br>such as breast, liver, kidney and prostate. The Easy Core Biopsy System is a<br>sterile, single-use biopsy needle. |
| Biocompatibility | The Easy Core Biopsy System has been tested for biocompatibility per ISO<br>10993. All data demonstrate this device is biocompatable for its intended use. |
| Summary of<br>Substantial<br>Equivalence | The Easy Core Biopsy System has been tested and compared to the predicate<br>device. All data gathered demonstrate this device as substantially equivalent.<br>No new issues of safety or efficacy have been raised. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY - 6 2004

RE: K040893

Ms. Christine Cameron Regulatory Specialist II Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760

## Trade/Device Name: Easy Core Biopsy System Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instruments

Regulatory Class: II Product Code: 78 FCG Dated: April 5, 2004 Received: April 6, 2004

Dear Ms. Cameron:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K040893
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## Indications For Use

| 510(k) Number (if known) | Unknown K040893 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Easy Core™ Biopsy System |
| Indications for Use | The Easy Core Biopsy System is indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs/tumors or masses for histological analysis. Soft tissue sampling includes but not limited to organs such as breast, liver, kidney and prostate. |

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 040843 510(k) Number.